(112 days)
Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement. The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.
The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards: ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials; ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .
This 510(k) summary (K093338) describes a dental device, specifically a "Self adhesive composite luting cement." The provided document does not describe a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices through conformity with recognized dental standards and FDA guidance documents.
Therefore, many of the requested sections related to acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an AI/ML device performance study. For this dental cement, acceptance criteria are generally defined by performance benchmarks within the referenced ISO standards (ISO 7405:1997 and ISO 4049:2000) for biocompatibility, physical properties, and luting characteristics. The document states the device "complies with the requirements set forth in the following standards," which implies it met the acceptance criteria implicitly defined by these standards. No specific numerical performance results are reported in this 510(k) summary.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 7405:1997) | Complies with ISO 7405:1997 (implied acceptable biocompatibility) |
| Polymer-based Filling, Restorative, and Luting Material Properties (per ISO 4049:2000) | Complies with ISO 4049:2000 (implied acceptable physical and mechanical properties) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a traditional medical device submission based on compliance with performance standards and substantial equivalence, not an AI/ML device evaluated with a test dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment by experts is not described for this type of device submission. Performance is assessed against international standards.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" (or basis for verification) is established by the performance requirements and test methods defined within the referenced international standards:
- ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
- ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials
Compliance with these standards implies the device has met the established benchmarks for safety and performance for its intended use.
8. The sample size for the training set
Not applicable. Training sets are relevant for AI/ML models, not for this type of traditional medical device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Submission Approach:
The K093338 submission for the "Self adhesive composite luting cement" is an Abbreviated 510(k). This type of submission relies on:
- Conformance to Recognized Standards: The primary method for demonstrating safety and performance is by showing compliance with specific FDA-recognized international standards (ISO 7405:1997 and ISO 4049:2000). These standards contain established test methods and acceptance criteria for dental materials.
- Substantial Equivalence: The device's components and indications are compared to already legally marketed predicate devices, implying similar safety and effectiveness profiles.
The document does not contain raw study data, specific performance metrics, or details of a clinical trial that would be required for an AI/ML device or a novel device proving entirely new performance claims. Instead, it asserts compliance with established standards and guides.
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Kog3338
510(k) Summary
| Trade Name: | Self adhesive composite luting cement | |
|---|---|---|
| Sponsor: | DMG USA, Inc.23 Frank Mossberg DriveAttleboro, MA 02703Registration # not yet assignedOwner/Operator No. 9005969 | FEB 12 2010 |
| Device Generic Name: | Self adhesive composite luting cement | |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
Product Description
Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement.
Indications for Use:
The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.
Device Description:
The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards:
- ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials
- ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .
Predicate Devices:
The components of the proposed Self adhesive composite luting cement are substantially equivalent to several currently marketed dental cements including the following:
Self adhesive composite luting cement:
| ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.Dran | 100 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 0000 0000 0000 0000 00000000000000200 - 10 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 14 -STATES CONTRACTOR COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CO- FILL PROSE ALL.I PAI I SIGI I .1 / Wa = 1 = = 1Antoner of the control of the children to the charges of the charges of | |
|---|---|---|
| Jnicem | KOR72973M | |
| Maxcem | K041474 (Sybron Dental Specialties, inc.I |
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998) and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005).
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Conclusion:
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Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Self adhesive composite luting cement has been shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2010
DMG USA, Incorporated C/O Ms. Pamela Papineau Delphi Medical Device Consulting 5 Whitcomb Avenue Aver, Massachusetts 01432
Re: K093338
Trade/Device Names: Self Adhesive Composite Luting Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 22, 2010 Received: January 27, 2010
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Papineau
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ___K093338
Device Name: Self adhesive composite luting cement
Product Indications for Use:
Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement.
The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.
OR Prescription Use X (Per 21 CFR 801 Subpart D)
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin M. So, MSR
(Division Sion-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093398
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.